Clearance Summary
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 received FDA 510(k) clearance under submission number K071597, sponsored by Dade Behring, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2008-06-04.
- Submission: K071597
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2008-06-04
Classification & Regulation
This clearance is catalogued under FDA product code LOJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.